Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Food and Drug Administration Rapid Response Surveys, 47599-47600 [2010-19357]
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Federal Register / Vol. 75, No. 151 / Friday, August 6, 2010 / Notices
Dated: August 2, 2010.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2010–19396 Filed 8–5–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0380]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Generic Food and
Drug Administration Rapid Response
Surveys
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the use of rapid response surveys to
obtain data on safety information to
support quick-turnaround
decisionmaking about potential safety
problems or risk management solutions
from health care professionals, hospitals
and other user-facilities (e.g., nursing
homes, etc.); consumers; manufacturers
of biologics, drugs, and medical devices;
distributors; and importers when FDA
must quickly determine whether or not
a problem with a biologic, drug, or
medical device impacts the public
health.
DATES: Submit either electronic or
written comments on the collection of
information by October 5, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
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SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.Capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined in
44 U.S.C. 3502(3) and 5 CFR 1320.3(c)
and includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires Federal agencies
to provide a 60-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Generic Food and Drug Administration
Rapid Response Surveys—(OMB
Control Number 0910–0500)—Extension
Section 505 of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
355), requires that important safety
information relating to all human
prescription drug products be made
available to FDA so that it can take
appropriate action to protect the public
health when necessary. Section 702 of
the act (21 U.S.C. 372) authorizes
investigational powers to FDA for
enforcement of the act. Under section
519 of the act (21 U.S.C. 360i), FDA is
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
47599
authorized to require manufacturers to
report medical device-related deaths,
serious injuries, and malfunctions to
FDA; to require user facilities to report
device-related deaths directly to FDA
and to manufacturers; and to report
serious injuries to the manufacturer.
Section 522 of the act (21 U.S.C. 360l)
authorizes FDA to require
manufacturers to conduct postmarket
surveillance of medical devices. Section
705(b) of the act (21 U.S.C. 375(b))
authorizes FDA to collect and
disseminate information regarding
medical products or cosmetics in
situations involving imminent danger to
health or gross deception of the
consumer. Section 903(d)(2) of the act
(21 U.S.C. 393(d)(2)) authorizes the
Commissioner of Food and Drugs to
implement general powers (including
conducting research) to carry out
effectively the mission of FDA. These
sections of the act enable FDA to
enhance consumer protection from risks
associated with medical products usage
that are not foreseen or apparent during
the premarket notification and review
process. FDA’s regulations governing
application for agency approval to
market a new drug (21 CFR part 314)
and regulations governing biological
products (21 CFR part 600) implement
these statutory provisions. Currently
FDA monitors medical product related
postmarket adverse events via both the
mandatory and voluntary MedWatch
reporting systems using FDA Forms
3500 and 3500A (OMB control number
0910–0291) and the vaccine adverse
event reporting system. FDA is seeking
OMB clearance to collect vital
information via a series of rapid
response surveys. Participation in these
surveys will be voluntary. This request
covers rapid response surveys for
community based health care
professionals, general type medical
facilities, specialized medical facilities
(those known for cardiac surgery,
obstetrics/gynecology services, pediatric
services, etc.), other health care
professionals, patients, consumers, and
risk managers working in medical
facilities. FDA will use the information
gathered from these surveys to obtain
quickly vital information about medical
product risks and interventions to
reduce risks so the agency may take
appropriate public health or regulatory
action including dissemination of this
information as necessary and
appropriate.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\06AUN1.SGM
06AUN1
47600
Federal Register / Vol. 75, No. 151 / Friday, August 6, 2010 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Annual Frequency
per Response
200
30
1 There
Dated: August 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0084]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Pretesting of
Tobacco Communications
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by September
7, 2010.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
SUMMARY:
sroberts on DSKD5P82C1PROD with NOTICES
6,000
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comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
the title ‘‘Pretesting of Tobacco
Communications.’’ Also include the
FDA docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794,
JonnaLynn.Capezzuto@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Pretesting of Tobacco
Communications—0910–NEW
[FR Doc. 2010–19357 Filed 8–5–10; 8:45 am]
AGENCY:
Hours
per Response
Total Hours
.5
3,000
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA projects 30 emergency risk
related surveys per year with a sample
of between 50 and 200 respondents per
survey. FDA also projects a response
time of 0.5 hours per response. These
estimates are based on the maximum
sample size per questionnaire that FDA
can analyze in a timely manner. The
annual frequency of response was
determined by the maximum number of
questionnaires that will be sent to any
individual respondent. Some
respondents may be contacted only one
time per year, while other respondents
may be contacted several times
annually, depending on the human
drug, biologic, or medical device under
evaluation. It is estimated that, given the
expected type of issues that will be
addressed by the surveys, it will take 0.5
hours for a respondent to gather the
requested information and fill in the
answers.
ACTION:
Total Annual
Responses
In order to conduct educational and
public information programs relating to
tobacco use, as authorized by section
1003(d)(2)(D) of the Federal Food Drug
and Cosmetic Act (21 U.S.C. section
393) and to develop effective tobaccorelated communications as authorized
by the Family Smoking Prevention and
Tobacco Control Act (Tobacco Control
Act), FDA must conduct research and
studies relating to the control and
prevention of disease (also authorized
by section 301 of the Public Health
Service Act (42 U.S.C 241(a)). In
conducting such research, FDA will
employ formative pretests to assess the
likely effectiveness of tobacco
communications with specific target
audiences. The information collected
will serve two major purposes. First,
formative research will provide critical
knowledge about target audiences such
as adolescents, adults, health care
professionals, and tobacco retailers.
FDA must first understand critical
influences on people’s decisionmaking
process when choosing to use, not use,
or quit using tobacco products. In
addition to understanding the
decisionmaking processes of adults, it is
also critical to understand the
decisionmaking processes among
adolescents (ages 13 to 17), where
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Frm 00078
Fmt 4703
Sfmt 4703
communications will aim to discourage
tobacco use before it starts. FDA must
also understand the general beliefs of
retailers in the tobacco product supply
chain. Retailers play a key role in the
success of tobacco control as they are
directly impacted by many of the
regulations FDA will issue under the
Tobacco Control Act. FDA must
determine retailers’ informational needs
and the most effective communication
channels and formats for reaching and
educating them about new regulations.
This knowledge will allow FDA to
engage retailers as partners in tobacco
control by better equipping them with
the tools needed to comply with these
regulations. FDA will apply knowledge
of these decisionmaking processes to
design effective communication
strategies and messages. Second, initial
testing will allow FDA to assess the
potential effectiveness of messages and
materials in reaching and successfully
communicating with their intended
audiences. Pretesting messages with a
sample of the target audience will allow
FDA to refine messages while they are
still in the developmental stage. By
utilizing appropriate qualitative and
quantitative methodologies, FDA will be
able to: (1) Better understand
characteristics of the target audience—
its attitudes, beliefs, and behaviors—and
use these in the development of
effective risk communications; (2) more
efficiently and effectively design
messages and select formats that have
the greatest potential to influence the
target audience’s attitudes and behavior
in a favorable way; (3) determine the
best promotion and distribution
channels to reach the target audience
with appropriate messages; and (4)
expend limited program resource
dollars wisely and effectively.
In the Federal Register of March 1,
2010 (75 FR 9225), FDA published a 60day notice requesting public comment
on the proposed collection of
information. FDA received comments
from four public entities, including two
corporations, one nonprofit
organization, and one city health
department. Comments supported FDA
taking a science-based approach to its
communication activities. None of the
comments objected to the estimated
annual reporting burden or questioned
E:\FR\FM\06AUN1.SGM
06AUN1
Agencies
[Federal Register Volume 75, Number 151 (Friday, August 6, 2010)]
[Notices]
[Pages 47599-47600]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19357]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0380]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Generic Food and Drug Administration Rapid Response
Surveys
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the use of rapid response
surveys to obtain data on safety information to support quick-
turnaround decisionmaking about potential safety problems or risk
management solutions from health care professionals, hospitals and
other user-facilities (e.g., nursing homes, etc.); consumers;
manufacturers of biologics, drugs, and medical devices; distributors;
and importers when FDA must quickly determine whether or not a problem
with a biologic, drug, or medical device impacts the public health.
DATES: Submit either electronic or written comments on the collection
of information by October 5, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-3794, Jonnalynn.Capezzuto@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Generic Food and Drug Administration Rapid Response Surveys--(OMB
Control Number 0910-0500)--Extension
Section 505 of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 355), requires that important safety information relating to
all human prescription drug products be made available to FDA so that
it can take appropriate action to protect the public health when
necessary. Section 702 of the act (21 U.S.C. 372) authorizes
investigational powers to FDA for enforcement of the act. Under section
519 of the act (21 U.S.C. 360i), FDA is authorized to require
manufacturers to report medical device-related deaths, serious
injuries, and malfunctions to FDA; to require user facilities to report
device-related deaths directly to FDA and to manufacturers; and to
report serious injuries to the manufacturer. Section 522 of the act (21
U.S.C. 360l) authorizes FDA to require manufacturers to conduct
postmarket surveillance of medical devices. Section 705(b) of the act
(21 U.S.C. 375(b)) authorizes FDA to collect and disseminate
information regarding medical products or cosmetics in situations
involving imminent danger to health or gross deception of the consumer.
Section 903(d)(2) of the act (21 U.S.C. 393(d)(2)) authorizes the
Commissioner of Food and Drugs to implement general powers (including
conducting research) to carry out effectively the mission of FDA. These
sections of the act enable FDA to enhance consumer protection from
risks associated with medical products usage that are not foreseen or
apparent during the premarket notification and review process. FDA's
regulations governing application for agency approval to market a new
drug (21 CFR part 314) and regulations governing biological products
(21 CFR part 600) implement these statutory provisions. Currently FDA
monitors medical product related postmarket adverse events via both the
mandatory and voluntary MedWatch reporting systems using FDA Forms 3500
and 3500A (OMB control number 0910-0291) and the vaccine adverse event
reporting system. FDA is seeking OMB clearance to collect vital
information via a series of rapid response surveys. Participation in
these surveys will be voluntary. This request covers rapid response
surveys for community based health care professionals, general type
medical facilities, specialized medical facilities (those known for
cardiac surgery, obstetrics/gynecology services, pediatric services,
etc.), other health care professionals, patients, consumers, and risk
managers working in medical facilities. FDA will use the information
gathered from these surveys to obtain quickly vital information about
medical product risks and interventions to reduce risks so the agency
may take appropriate public health or regulatory action including
dissemination of this information as necessary and appropriate.
FDA estimates the burden of this collection of information as
follows:
[[Page 47600]]
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual Frequency per
No. of Respondents Response Total Annual Responses Hours per Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
200 30 6,000 .5 3,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA projects 30 emergency risk related surveys per year with a
sample of between 50 and 200 respondents per survey. FDA also projects
a response time of 0.5 hours per response. These estimates are based on
the maximum sample size per questionnaire that FDA can analyze in a
timely manner. The annual frequency of response was determined by the
maximum number of questionnaires that will be sent to any individual
respondent. Some respondents may be contacted only one time per year,
while other respondents may be contacted several times annually,
depending on the human drug, biologic, or medical device under
evaluation. It is estimated that, given the expected type of issues
that will be addressed by the surveys, it will take 0.5 hours for a
respondent to gather the requested information and fill in the answers.
Dated: August 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19357 Filed 8-5-10; 8:45 am]
BILLING CODE 4160-01-S